Registry and biobank for ocular complications from cancer therapy
Registry and Biobank of Patients With a History of Cancer Therapy
This study is collecting information and samples from cancer patients to see how their treatment might cause eye problems, helping to better understand and predict these issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06874283 on ClinicalTrials.gov |
What this trial studies
This study aims to collect data from patients at the University of Maryland who have undergone cancer therapy, focusing on those at risk for ocular complications such as graft versus host disease (GVHD) and inflammatory dry eye disease. Participants will undergo standard eye examinations, and biological specimens will be collected for analysis to gain insights into the immunologic and cellular mechanisms behind these ocular issues. The study will create a registry and biobank to better understand the pathogenesis of ocular toxicity and identify predictive factors for developing complications post-cancer therapy.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a history of allogenic stem cell transplant or cancer therapy, who do not have significant pre-existing eye diseases.
Not a fit: Patients with a history of significant eye diseases unrelated to cancer therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of ocular complications in cancer patients, enhancing their quality of life.
How similar studies have performed: While there have been studies on ocular complications in cancer therapy, this specific approach of creating a biobank for detailed immunologic analysis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for the Cancer Therapy Group: * Adult patients (greater than 18 years of age) * Deny a history of eye diseases (excluding cataract, glaucoma, mild dry eye disease, or history of cataract or refractive surgery) * Patients who have a history of allogenic HSCT with all stem cell sources including bone marrow, PBSC, cord AND/OR patients with a history of prior cancer therapy including BMT, chemotherapy, and immunotherapy * Patients will be recruited after their HSCT or cancer therapy at their ophthalmology appointment * Patients can be included with a history of prior cancer therapy including chemotherapy, BMT, immunotherapy. Prior cancer therapy must be identified and documented. * The patient must be able to understand and sign and date the informed consent form approved by the IRB. Inclusion Criteria for the Control Group: * No history of cancer or cancer therapy in the past * Adult patients (greater than 18 years of age) * Deny a history of eye diseases (excluding cataract, glaucoma, mild dry eye disease, or history of cataract or refractive surgery) * The patient must be able to understand and sign and date the informed consent form approved by the IRB. Exclusion Criteria for the Cancer Therapy Group: * Vulnerable populations: neonates, children, prisoners, institutionalized individuals * Inability or refusal to provide informed consent. * History of ocular surgery or ocular disease (except refractive or cataract surgery, mild dry eye disease, or glaucoma). Exclusion Criteria for the Control Group: * Vulnerable populations: neonates, children, prisoners, institutionalized individuals * Inability or refusal to provide informed consent. * History of ocular surgery or ocular disease (except refractive or cataract surgery, mild dry eye disease, or glaucoma). * History of cancer or cancer therapy including chemotherapy, immunotherapy, BMT.
Where this trial is running
Baltimore, Maryland
- Stoler Outpatient Cancer Center at the University of Maryland — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: Sarah Sunshine, MD
- Email: ssunshine@som.umaryland.edu
- Phone: 667-214-1292
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.